Bridging the Gap to Improve Mental Health Treatment Utilization

Sponsor
University of Pittsburgh (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04558489
Collaborator
Kaiser Foundation Research Institute (Other), National Institute of Mental Health (NIMH) (NIH)
49
Enrollment
1
Location
1
Arm
5
Anticipated Duration (Months)
9.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Bridging the Gap aims to improve access to effective mental health treatment in a primary care setting through utilization of single session growth mindset interventions for parents and for youths. This project will also utilize focus groups and qualitative interviews to gain feedback on a single session online intervention in a rural pediatric primary care practice.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: IPR + GMI
N/A

Detailed Description

Bridging the Gap purposes to collect feedback on a single session growth mindset intervention (GMI) for parents and for youths designed to instill beliefs that personal traits (including mental health problems) are malleable. Feedback will also be collected to identify ways to improve implementing single session interventions (SSIs) in a primary care setting as well as identifying the impact on work-flow of this GMI. Patients presenting with depression and/or anxiety will all receive the GMI and will have the option of participating in focus groups/interviews pre and post-intervention to provide feedback on the intervention. Providers at this rural pediatric primary care practice will also have the chance to participate in focus groups/interviews pre and post-intervention implementation.

Assignment of Interventions: As an open trial, all participants will be assigned to the intervention arm and will receive the GMI.

This study is an open trial pilot project to collect feedback on a single session growth mindset intervention (GMI) (n=25 youth/caretaker dyads). Feedback from pre and post-intervention focus groups/interviews will be collected for 8 parents, 8 youth, and 8 treatment providers.

The aims of the study are to:
  1. Collect feedback from providers, parents, and participants pre and post- GMI to identify ways to improve implementing single session interventions (SSIs) in a primary care setting.

  2. Identify the impact on work-flow of using an online single session called Growth Mindset Intervention in a primary care setting.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
49 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
This study will use an open trial design, where all participants will receive the Growth Mindset Intervention.This study will use an open trial design, where all participants will receive the Growth Mindset Intervention.
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Bridging the Gap: Utility of a Single Session Intervention to Change Attitudes Toward Treatment, and Improve Acceptance of Further Psychotherapy for Depressed and/or Anxious Youth and Their Caretakers
Anticipated Study Start Date :
Oct 30, 2021
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
Apr 1, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: IPR + GMI

Participants receiving IPR + GMI will complete a 30-minute on-line intervention via qualtrics that covers the following topics: (1) Educate youth and caregiver that thoughts and emotions are not fixed but are malleable and subject to change; (2) provide youth and families with a brief intervention that instills hopefulness through an action plan for managing internalizing symptoms; (3) assist with developing system of support to access during times of distress; and (4) educate the caregiver on the importance of these interventions.

Behavioral: IPR + GMI
The IPR + GMI intervention aims to impact reported hopelessness, attitudes to treatment, and view of self as changeable as well as targets treatment attendance and utilization.

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in child and parental attitudes towards therapy at 4 weeks [Baseline vs. 4 week follow-up]

    Child and parental attitudes towards therapy will be assessed via Attitudes Towards Therapy Scale, as the primary outcome of Bridging the Gap. Scores on this one question assessment range from 0= view of therapy as not at all helpful to 10= view of therapy as very helpful.

  2. Change from baseline in view of emotions as changeable at 4 weeks [Baseline vs. 4 week follow-up]

    Child and parental views of personality as changeable will be assessed via Implicit Theory of Emotions Scale, as the primary outcome of Bridging the Gap. The Implicit Theory of Emotion contains 4 questions, with two incremental items and two entity items. Each item is rated using a 7-point Likert scale with 1= strongly disagree and 7= strongly agree. The two entity items are reverse-scored. Scores range from 4-28 and higher scores indicate a view of emotions as changeable.

  3. Change from baseline in view of personality as changeable at 4 weeks [Baseline vs. 4 week follow-up]

    Child and parental views of personality as changeable will be assessed via Implicit Theory of Personality Questionnaire, as the primary outcome of Bridging the Gap. The Implicit Theory of Personality Questionnaire contains 3 questions with a range of scores from 3 to 18, with lower scores indicating a view of personality as changeable.

  4. Hopelessness [Up to 4 weeks after baseline]

    Child and parent hopelessness will be assessed via Beck Hopelessness Short Scale, as the primary outcome of Bridging the Gap. This 4-item scale is totaled using the sum of item scores. Scores range from 0-12, with higher scores indicating more hopelessness.

Secondary Outcome Measures

  1. Anxiety Severity [Up to 4 weeks after baseline]

    Child anxiety severity will be assessed via SCARED 5-item, as a secondary outcome of Bridging the Gap. This 5-item assessment has scores ranging from 0-10, with higher scores indicating more self-reported anxiety.

  2. Depression Severity [Up to 4 weeks after baseline]

    Child and parent depression severity will be assessed via MFQ questionnaire, as a secondary outcome of Bridging the Gap. The MFQ Child version has scores ranging from 0-66, with a higher score indicating more severe depression. The MFQ Parent version has scores ranging from 0-69, with higher score indicating more severe depression.

  3. Psychological distress [Up to 4 weeks after baseline]

    Child and parent psychological distress will be assessed via PHQ4 questionnaire, as a secondary outcome of Bridging the Gap. The PHQ4 contains 4 questions, 2 questions relating to depression and 2 questions relating to anxiety, with scores ranging from 0-12. Higher scores on the PHQ4 indicate more severe psychological distress.

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients presenting with depression and/or anxiety, as identified by the patient, parent, or provider

  • 10-18 years old

  • CBT is recommended by provider. Receipt of mental health services upon enrollment will be monitored but will not preclude participation

  • Participants must reside with a legal guardian

  • English speaking

Exclusion Criteria:
  • Participants will be excluded if they have conditions that might impair their ability to effectively engage in Bridging the Gap, i.e

  • Those in a current manic episode

  • Those in a current psychotic episode

  • Those diagnosed with Autism Spectrum Disorder

  • Those who have issues with substance abuse

  • Participants with current involvement with child welfare.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Children's Community Pediatrics (CCP- Armstrong Kittanning) of Children's Hospital of Pittsburgh of UPMCKittanningPennsylvaniaUnited States16201

Sponsors and Collaborators

  • University of Pittsburgh
  • Kaiser Foundation Research Institute
  • National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Tina Goldstein, PhD, University of Pittsburgh
  • Study Director: David Brent, MD, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tina R Goldstein, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT04558489
Other Study ID Numbers:
  • STUDY19110071
  • P50MH115838-02
First Posted:
Sep 22, 2020
Last Update Posted:
Oct 14, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tina R Goldstein, Associate Professor, University of Pittsburgh
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 14, 2021